Assistant Professor Institute of Process and Particle Engineering
Graz University of Technology
Assistant Professor at Graz University of Technology, Austria and Principal Scientist / Department Head, Advanced Products and Delivery at Research Center Pharmaceutical Engineering (RCPE), Graz, Austria. Amrit is trained in pharmaceutics, and has a broad interest in physical chemistry of formulations and pharmaceutical material engineering. He has long standing activities and an interest in screening, engineering, stabilization and characterization of pharmaceutical solids intended for oral and inhalation routes. His current work also involves predictive knowledge/model development for physical and chemical stability of pharmaceutical solids utilizing material science principles. Recently, he is working towards advancing the predictive knowledge of in vitro biopharmaceutics methodologies via elucidation of multi-factorial physical and chemical process governing drug dissolution and release from conventional to advanced solid dosage forms.
Andreas Bernkop-Schnürch
Professor
University of Innsbruck
Oral delivery of biologics including therapeutic peptides and proteins as well as DNA/RNA-based drugs is certainly a great challenge. In order to reach the systemic circulation after oral dosing these hydrophilic macromolecular drugs have to overcome various barriers being encountered with the GI-tract. In particular the enzymatic barrier (I) being represented by secreted and membrane bound enzymes cleaving them in inactive fragments, the sulfhydryl barrier (II) causing unintended thiol/disulphide exchange reactions between thiols being present in the GI-tract and peptide/protein drugs, the mucus gel barrier (III) restricting macromolecules from reaching the absorption membrane and the absorption membrane barrier per se (IV) are responsible for a comparatively very low oral bioavailability. In order to overcome these barriers, various technologies were explored. Among them, self-nano- and micro-emulsifying drug delivery systems (SNEDDS and SMEDDS), collectively named as self-emulsifying drug delivery systems (SEDDS) have received considerable attention within recent years. Due to the complexation with lipophilic excipients biologics can be incorporated in the lipophilic phase of SEDDS. Once emulsified in the GI-tract to lipid droplets in the size of 30-200 nm, SEDDS provide a protective effect towards a presystemic metabolism, efficiently permeate the intestinal mucus gel layer in order to reach the absorption membrane and provide permeation enhancing properties. Moreover, as SEDDS can be produced in a very simple and cost effective manner, they might have the potential of game-changing delivery systems for the oral administration of biologics.
Take Home Message:
SEDDS are not carrier systems in that you can simply incorporate your drug gaining a sufficiently high oral bioavailability. The potential of SEDDS lies in the huge flexibility for the design of appropriate formulations fully addressing the peculiar properties of each biologic. Within this development process formulation IP is generated.
A short interview with you
Tell us a little-known fact about yourself! In parallel to my academic career I run a pharmacy standing behind the counter and selling drugs.
What do you foresee as being the biggest game changers in your industry over the next 5-10 years? So-called ‘drug delivery platform technologies’ are not anymore the future. In particular for the delivery of biologics the game will change to drug delivery companies providing individual solutions for each of these drugs based on a high expertise in the particular field.
What advice would you give a younger you? If certain strategies/concepts do not prove to be a success within an expected time period, to be much earlier open for alternatives.
What are your three biggest challenges on a day-to-day basis? 3x Doing research in parallel to all these teaching and administrate responsibilities
What has been the proudest moment of your career to date? Realizing that first drugs being based on a technology (thiomer-technology) I have invented and developed over the years are reaching the global pharmaceutical market.
Aniket Badkar
Associate Director Biologics Product Development
Allergan
Dr Bastiaan Dickhoff
Product Application Specialist OSD
DFE Pharma
Dr Bastiaan Dickhoff joined the T&I department team at DFE Pharma in 2014 in the capacity of Application Specialist OSD. Bastiaan has been working on assisting in application development of excipients in area of Oral Solid Dose Forms based upon fundamental knowledge of DFE Pharma’s excipients and advances in powder technology. In addition, he is from a Technology and Innovation point of view responsible for the outcome of external collaborations. Prior to working at DFE Pharma Bastiaan held two (2) roles concerning the effect of powders in food and pharma at RSSL (which is part for Mondelez International (UK)) and prior to that Bastiaan has worked between 2005-2012 for GlaxoSmithKline (UK) in various roles.
Bastiaan holds a PhD from the department Pharmaceutical Technology and Biopharmacy at Groningen University, The Netherlands where he specialized in the relationship between the role of lactose (excipient) and API for inhalation purposes.
Product Quality Steward Eylea and Anetumab Ravstantine
Bayer
Brian Henry
Vice President Drug Product Design
Pfizer
Richard Wedge
Compliance Lead
Pfizer Ltd
Dr. Christian Lotz
Director, Business Development
Pfanstiehl
Christian Lotz studied Physical Chemistry at the University of Bochum and did his doctorate in Physical Chemistry at the University of Essen. He started his Industry career at Lipoid GmbH, a GMP manufacturer of parenteral grade phospholipids, in the sales department with technical and regulatory support functions. Since April 2015 Christian is working as BD Director EMEA at Pfanstiehl, world’s leading manufacturer of low endotoxin and high purity GMP parenteral grade carbohydrate based excipients, providing commercial and technical support to the EU customer base. Christian has 15 years of experience in GMP relevant sourcing and marketing activities of pharmaceutical raw materials.
Christoph Brandenbusch
Associate Professor
University of Dortmund
Clive Wilson
J.P. Professor of Pharmaceutics
University of Strathclyde
Daniel Schweizer
DP Project Lead TD NBE’s
Novartis
Professor Duncan Craig
Director, Chair in Drug Delivery
UCL School of Pharmacy
Filippos Kesisoglou
Senior Principal Scientist, Biopharmaceutics and Pharmaceutical Sciences
MSD
Fred Monsuur
TCS and Business Development Manager Excipients
W.R. Grace
Grégoire joined F.Hoffmann-La Roche (Basel, Switzerland) beginning of 2015 in Pharmaceutical Technical Development Biologics Europe. In his new role as Head of Drug Delivery, Grégoire is responsible for the implementation of advanced drug delivery products in Roche’s development portfolio. He works with sterile products and his current focus areas are within sustained release products for ophthalmology and parenterals, as well as within nanotechnologies for targeted drug delivery. Before joining Roche, Grégoire worked in several positions in Pharmaceutical Drug Development at Ferring Pharmaceuticals A/S (Copenhagen, Denmark). In his last position, he established and led a successful early stage development group, having CMC responsibility over a diversified portfolio of peptide and biological drugs, and he led also the company’s drug delivery innovation in the areas of sustained parenteral delivery, enhanced (non-parenteral) peptide delivery and long acting formulations of proteins. Grégoire is educated in Chemical Engineering from the Institut National des Sciences Appliquées (INSA) in Rouen, France. He specialized in polymers for therapeutic applications with a doctorate at the University of Montpellier under the supervision of Prof. Michel Vert. After a few years as Head of Polymer Development with Phusis Matériaux Biorésorbables, he moved on to the University of Geneva in Switzerland, working on sustained release formulations of a proprietary peptide drug for prostate cancer, in the group of Prof. Robert Gurny. During his career, Grégoire co-supervised several PhDs and Master students, participated to two EU-funded consortium projects (Brite Euram and FP7), and is the author or co-author of ca. 20 scientific publications and 6 patent families.
ABSTRACT:
The presentation is illustrating some of the challenges with the pharmaceutical development of products based on advanced drug delivery principles. The first example is taken from the field of injectables, show casing the switch from intravenous infusion to subcutaneous injection of biologics that was successfully applied to several Roche products. This switch required the development of a high concentration formulation combined with a co-formulation development together with a novel excipient enabling subcutaneous injection of large volumes. The second example is dealing with one route of localized drug delivery, namely the ocular route, and more specifically current approaches for long acting ocular delivery of biologic drugs. Here again, innovative technologies are facing the reality check of pharmaceutical development, but are nevertheless progressing in the clinics, showing big promise of patient treatment improvement.
A short interview with you
Tell us a little-known fact about yourself! I am originating from a wine maker family in Alsace, Ribeauvillé
What do you foresee as being the biggest game changers in your industry over the next 5-10 years? Advanced Drug delivery systems to enable more efficient and safer treatment for patients
What advice would you give a younger you? Medical research needs talented young people able to flexibly adapt to an incredibly fast changing environment
What are your three biggest challenges on a day-to-day basis? To catch up with knowledge available in open world. To accelerate development timelines. To anticipate the future.
What has been the proudest moment of your career to date?Being part of the core team obtaining global approval in US and EU of Firmagon a self-depoting peptidic GnRH antagonist against prostate cancer
Hannah Batchelor
Senior Lecturer in Pharmaceutics, Formulation and Drug Delivery
University of Birmingham
Helen Hao Hou
Scientist, Small Molecule Pharmaceutical Sciences
Genentech
Helen Williams
Associate Principal Scientist
AstraZeneca
I graduated from Southampton University with a Masters of Chemistry degree in the summer of 1998 and started working for Zeneca a couple of months later. I have spent the last 20 years working as an analytical chemist in pharmaceutical development at AstraZeneca in Macclesfield, UK. I specialized as an expert in Electron Paramagnetic Resonance spectroscopy and more recently have spent the last 5 years focusing in Predictive Stability, as an Associate Principal Scientist. I am a member of the IQ Risk-Based Predictive Stability Working Group and became a Charter Chemist with the RSC in 2014.
Herve Barre
Chef de projet Sterilisation WW, Industrial Engineer
BD Medical Pharmaceutical Systems
Mechanic and Automation Bachelor degree in Rennes University, France.
25 years in BD Medical Pharmaceutical System.
I’m engineering project manager for manufacturing process industrialization of glass prefilable syringes for the pharmaceutical industry.
After spending more than 2 decades in several posts in BDM-PS Engineering, R&D and manufacturing department -where I accumulated skills and recognized expertize on the full glass syringes process until Sterilization-, I decided 2 years ago to go back to the sterilization world.
Today I’m leading the WW engineering sterilization roadmap for BD Medical Pharmaceutical system to support capacity requirement, to harmonize practices and processes, to innovate, and to conduct and/or support continuous improvement initiatives.
James A. McCoy
Staff Scientist, Head of Sterilization R&D/Innovation Center
BD Medical Pharmaceutical Systems
Jatin Patel
Head – Oral Product Design & Development
Bristol-Myers Squibb
Jean-René Authelin
Global director of Pharmaceutical Engineering
Sanofi
Jean-René Authelin has an Engineer degree in chemical Engineering from ENSIC (Nancy France), and a PhD from The Institut National Polytechnique de Lorraine (France). He joined Rhone Poulenc in 1988 as a Chemical Engineer. In the 90’s he founded the Physical Quality function, dedicated to the API crystallization, drying, polymorphism where he was the Global head in Rhone Poulenc Rorer, Aventis and finally Sanofi . In 1988, JR Authelin was nominated Global Head of Pharmaceutical Engineering. Domains of interest of JRA include: thermodynamics of hydrates, drug polymorphism, amorphous solids physics, drug stability, crystallization, nanoparticles engineering and processing, drying , milling; spray drying, fluid bed granulation, roller compaction, freeze drying. JR Authelin cooperated with very famous scientists like Prof J.Villermaux, P de Gennes (Nobel price of Physics 1991). Jean René Authelin is the author or co-author of 14 publications or book chapters and the co-inventor of 9 patents
Jerome Mantanus
Head of Formulation and Process Characterisation
UCB
Joel Richard
Senior Vice President, Peptides
Ipsen
Juan Irache
Professor of Pharmaceutical Technology
University of Navarra
Jukka Rantanen
Professor Pharmaceutical Technology
University of Copenhagen
Prof. Dr. Karsten Mäder
Head of Pharmaceutical Technology
Martin Luther University Halle-Wittenberg
Kaspar van den Dries
Senior Director and Principle Scientist, Solid Dose Development
Patheon, Part of Thermo Fisher Scientific
Kaspar van den Dries, MSc, PhD. Dr. van den Dries leads the European R&D team in the development of innovative softgel formulations, processes and technologies. He is an expert in the formulation of poorly soluble compounds and self-emulsifying drug delivery systems with experience spanning the entire solid dosage form development cycle.
Kathrin Spielberger
Lab Head Formulation Development
Sanofi
Kenneth Graham
Senior Fellow Scientist, Associate Director
Regeneron
Kristof Kimpe
Principal Scientist
Janssen Pharmaceutica (a division of Johnson & Johnson)
Dr. Kristof Kimpe obtained a master degree in chemistry at the university of Leuven in 1999 and received his Ph.D. in chemistry in 2003 at the same university. He joined Janssen Pharmaceutica in 2005 and assumed global, end-to-end responsibility for excipients. In 2016 Dr. Kimpe joined the preformulation group of the pharmaceutical sciences department, supporting drug product development all the way from pre-clinical to commercial formulations.
Lorenz Meinel
Chair for Drug Formulation and Delivery
Wurzburg University
Márcio Temtem
Associate Director for Drug Product Development
Hovione
Márcio Temtem joined the Hovione in 2008 and has been since involved in the development of the Particle Design and Drug Product Business of the company. In the role of a scientist, group Leader or manager, Marciohas been involved in the development of multiple commercial and latest age programs in the field of solubility enhancement, particularly in the area of amorphous solid dispersions by spray drying, taste masking by spray congealing, microfluidization assisted processes and jetmilling.
Marcio is currently Associate Director for Drug Product Development at Hovione leading the R&D efforts in the field of particle engineering, oral solids dosage forms and inhalation.
Márcio is a PhD in Chemical Engineering with several papers and patents published in topics such as Green Chemistry, Controlled Release, Inhalation, Drug Product, Particle Engineering and Solubility enhancement.
Manfred Ogris
Professor Pharmaceutical Sciences, Head of the Laboratory for Macromolecular Cancer Therapeutics
Division of Clinical Pharmacy and Diagnostics Vienna University
Markus Krummer
Head of Continuous Manufacturing
Novartis
Martin McLoughlin
Head of Device Development
Bristol-Myers Squibb
Dr. Matthias Rischer
Director Drug Delivery & Innovation Projects
Losan Pharma
Chemist by education; since 1992 in the pharmaceutical industry; 10 years in pharmaceutical industry in development; 10 years in Biotec (development, production, quality); since 2011 working for Losan Pharma GmbH; responsible for the strategic development and new development platforms in the drug delivery formulation and application field
Mike Hooven
President and CEO
Enable Injections, Inc.
Mike has over 30 years of experience in the medical device industry in a broad variety of technical and clinical areas. He is the founder of five medical device companies and holds over 100 issued and pending US patents. He earned a BS in Physics and a Master of Science in Mechanical Engineering from the University of Michigan.
Muriel Didier
Human Factors Team Head
Novartis
Nikki Whitfield
Vice President CDMO Services
Quotient Sciences
Nikki possesses 23 years’ experience in the pharmaceutical industry and has previously held technical leadership positions in Quadrant Healthcare, Quadrant Drug Delivery and Elan where she was responsible for the development, transfer and scale up of both early phase and late phase spray-dried inhaled and topical products intended for both European and U.S. markets. In her previous position as a Project Director at Vectura, she led the early phase product development for two inhaled, orphan indication products and the late stage development for a novel sterile topical product. Nikki’s responsibilities at Quotient Sciences involve building the global formulation and manufacturing services business.
Olaf Queckenberg
Head of Chemical & Pharmaceutical Development
Bayer AG
Olaf Queckenberg studied pharmacy at the Universities of Berlin, Düsseldorf and Freiburg and did his doctorate at the chair of pharmaceutical chemistry of the Freiburg University. From 1994-1999 he was head of analytical development laboratories at Bayer in Leverkusen, Germany, and West Haven, USA. Since 1999 he has been the responsible manager for analytical development at Bayer Healthcare and since 2011 is the head of global pharmaceutical and chemical development at Bayer Pharmaceuticals Division
Olivier Brass
Formulation Scientist
Sanofi Pasteur
Philippe Lienard
CMC Discovery Coordinator
Sanofi
Rene Van Nostrum
Associate Professor
Utrecht University
Robert Meyer
Head of Innovation Technology Group, Pharmaceutical Commercialization
MSD
Prof. Dr. Sarah Hedtrich
Professor
Freie Universitat Berlin
Sofiya Yashchuk
Technical Applications Specialist
Roquette
Sofiya Yashchuk recently joined Roquette as Technical Applications Specialist within Roquette’s Customer Technical Services function. In her role, Sofiya supports BioPharmaceutical suite of ingredients & solutions Roquette brings to customers for use in upstream/downstream bioprocessing, and formulation of biopharmaceuticals. Roquette has a well-established history in naturally derived carbohydrates, polyols, and cyclodextrins; Sofiya supports technical developments of these existing tools in biopharma space, and drives the development of novel solutions to meet the challenges and rigor of biologic-medicines production.
Previous to joining Roquette, Sofiya worked for BASF (USA) in several divisions and functions, including her contribution as Business Development Manager for BASF Pharma Ingredients & Services, where she also focused on delivery and development of solutions for the BioPharmaceutical segment. Sofiya holds a Bachelor's Degree in Biochemistry from the University of Illinois and a PhD in Organic Medicinal Chemistry from Purdue University.
Stephen Buckley
Head of Department, Absorption and Biological MS
Novo Nordisk
Surendera Tyagi
Senior Vice President Head Innovation & Development Center
Fresenius Kabi USA
Svend Ludvigsen
Senior Scientific Director
Novo Nordisk
Prof. Dr. Sven Stegemann
Director Pharmaceutical Business Development
Lonza
Prof. Dr. Sven Stegemann is director, pharmaceutical business development at Capsugel, and professor of patient centric drug design and manufacturing at the Graz University of Technology, Austria. Over the course of his 20-year career at Capsugel, Dr. Stegemann has worked as an advisor to major pharmaceutical companies on ways to improve the design, development and manufacture of pharmaceutical products so they better address the individual needs of patients. In his academic role, Dr. Stegemann’s focuses his research on the rational development of patient centric drug products and their associated manufacturing technologies, as well as education and training of students and young scientists. Dr. Stegemann is the founder and chair of the AAPS Focus Group on Patient-Centric Drug Development, Product Design, and Manufacturing as well as the founder and President of the Geriatric Medicine Society.
Tarik Khan
Group Leader, Late-Stage Pharmaceutical and Processing Development
Roche
Thakur Raj Singh
Senior Lecturer in Pharmaceutics
Queen's University Belfast
Thomas Rades
Chair Pharmaceutical Sciences
University of Copenhagen
Vladimir P. Torchilin
Distinguished Professor and Director
Center for Pharmaceutical Biotechnology and Nanomedicine, Northeastern University
Yash Kapoor
Associate Principal Scientist
MSD
Yves Robin
R&D Director
PMC Isochem (PMC Group)
Yvonne Perrie
Chair Drug Delivery
University of Strathclyde
Gabriele Sadowski
Faculty Head
TU Dortmund University
Frantz Elbaz
Formulator Project Leader and Pharm Development QBD Network Leader
Novartis
Giustino Di Pretoro
Associate Director
Johnson & Johnson
Scott Ariagno
Head, Infusion and Reconstitution Systems / Director, Device Development and External Manufacturing
Shire
Dr. Jin Wang-Lai
Senior Director - Pharmaceutical Development
Adare Pharma
Carina Van Eester
Platform leader PFS and cartridges
Datwyler Sealing Solutions
Wolfgang Beier
CSO
Leon-nanodrugs
Sabine Eichling
Senior Scientist II, NBE High-Throughput and Advanced Formulation Sciences
Abbvie
Joe Barco
Senior Director of Marketing
Unchained Labs
Patrick Garidel
Associate Director Protein Science
Boehringer Ingelheim
Bertil Abrahamsson
Senior Principal Scientist
Astrazeneca
Tonio Hoche
Device Engineer
Roche Switzerland
Mostafa Nakach
Head of Pharmaceutical engineering-Paris
Sanofi
Ellen Verheyen
Senior scientist – Stability Expert
Janssen
Bastiaan de Leeuw
Head of Business Development – Drug Delivery
Cambridge Design Partnership
Gunilla Petersson
Science & Innovation Director
Astrazeneca Sweden
Eleonora Cerasoli
Senior Research Scientist
Albumedix
Tom Lawrie-Fussey
Digital Services Specialist
Cambridge Design Partnership
Ruchi Gupta
Scientist I
MedImmune
Isabel Sequeira Lopes
Senior Formulation Scientist/Project Coordinator
Chiesi
Dr. Meinolf Brackhagen
Senior TS&D Scientist / Pharma
Dow Chemical Company
Dr. Roberto Castangia
Global Sales Manager
biopharma group
Stéphanie Bureau
R&D Director
ADM-SIO
Richard Featherstone
Managing Director
Medical Device Usability Ltd
Patrick Anquetil
CEO
Portal Instruments
Gregoire Schwach
Head of Drug Delivery, Pharmaceutical Development and Supplies Biologics
EU F. Hoffmann-La Roche
Dr. Finn Bauer
Head of Solid Formulations R&D
Merck KGaA
Swapnil Khadke
Pharmaceutical Formulation and Development Specialist
University of Strathclyde
Professor Edward Hæggström
Chief Executive Officer
Nanoform
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Richard Zajicek
Head of Formulation Development, Cell and Gene Therapy Group
GSK
Christophe Tistaert
Senior Scientist
Janssen Belgium
Anette Müllertz
Professor, Head of Center
University of Copenhagen
Dr. Anette Müllertz is professor at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. She is head of Bioneer:FARMA, Danish Drug Development Center, a business unit of Bioneer A/S, based on a grant from the Danish Ministry of Science and Technology given to establish research based scientific services within the area of drug development. After receiving her PhD degree in lipid nutrition at the Technical University of Denmark, she went to work for Novo Nordisk A/S, on development of structured lipids, digestive lipases and digestion models, among other projects. In 1998 she joined the University of Copenhagen. She is heading the Physiological Pharmaceutics Research Group, focusing on developing predictive biopharmaceutics tools for oral drug delivery and lipid based drug delivery systems. She has >175 publications in international, peer-refereed journals (h-factor: 48 (Google Scholar)), as well as 10 book chapters; the majority of these being within the area of biopharmaceutics. She is / has been supervising 9 post docs, 40 PhD students and numerous master students, primarily at the University of Copenhagen, but also at other universities. She has been involved in the organization of many international meetings, both in Europe and the US and has been invited to speak at international meetings on more than 50 occasions. She is a driving force in the EU sponsored Innovative Medicines Initiative Consortium Oral Biopharmaceutics Tools (OrBiTo; http://www.orbitoproject.eu), as co-lead of the API characterization work package. She was the winner of the 2005 AAPS Lipid Based Drug Delivery Award and is in the steering committee of 2 AAPS Focus Groups (FGs); The Lipid-based Drug Delivery FG (Chair 2010-12) and the QbD and Product Performance FG (Chair 2013-15).